Retained Products After MiscarriageHYMMNNCT04751500
The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway for RPOC
A study testing Outpatient hysteroscopy, Expectant management and Medical management in people with Retained Products After Miscarriage, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Pregnancy tissue can be found remaining in the womb in up to 20% of women following a miscarriage. These "retained products of conception" (RPOC), which are diagnosed by transvaginal ultrasound, can cause prolonged bleeding, pain, infection, impaired fertility and therefore further psychological distress. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Retained Products After Miscarriage
- What is being tested?
- Outpatient hysteroscopy, Expectant management and Medical management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2021to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women above 18 years
- Women choosing either expectant or medical management of a first-trimester miscarriage ≤14 weeks gestation
- Women wanting to conceive as soon as possible after their miscarriage
- Consent to trial processes: (1) undergo follow-up with transvaginal ultrasound for the investigation of RPOC; (2) be randomised to outpatient hysteroscopy for confirmation and treatment or standard management; (3) accept trial follow up procedures - questionnaires, telephone interviews
Who cannot join
- Women below 18 years
- Women with findings suspicious of gestational trophoblastic disease
- Women with fever (≥38°C) or sepsis secondary to genital tract infection/endometritis
- Women who are unable to understand spoken and written English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial
Pregnancy tissue can be found remaining in the womb in up to 20% of women following a miscarriage. These "retained products of conception" (RPOC), which are diagnosed by transvaginal ultrasound, can cause prolonged bleeding, pain, infection, impaired fertility and therefore further psychological distress. Ineffective medical and surgical interventions place considerable burden on affected women and utilise scarce health care resources. Additionally, surgery is performed 'blindly' using a suction tube or metal curette where risks include perforation of the womb and scarring of the womb lining, both of which lead to delayed fertility and in the worst circumstances, infertility.
There is no current guidance on how to best investigate and manage RPOC. New surgical equipment allows RPOC removal under vision, using a specially designed telescope placed inside the womb (hysteroscopy). This precise technique may more successfully and less traumatically remove RPOC, minimising ongoing bleeding, the risk of womb perforation and scar tissue formation, thereby reducing the risk of infertility.
Read more
The investigators propose a pilot randomised controlled trial using routine transvaginal ultrasound to diagnose RPOC in women who choose non-surgical management of a first-trimester (≤14 weeks) miscarriage. This scan will be done 8 weeks post-miscarriage diagnosis. Women who have RPOC on this scan will be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy ('OPH') or 'standard treatment' (expectant, medical, surgical and/or antibiotic treatment).
Women who had RPOC will be followed-up at 14 weeks after randomisation to explore clinical outcomes (symptoms, quality of life) and use of additional healthcare resources (e.g. additional investigations / treatments / hospitalisations). All patients, no matter whether they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks after randomisation/ultrasound scan to determine clinical pregnancy rates and pregnancy outcomes. All patients who have had a miscarriage or have not fallen pregnant since entering the trial will be offered a hysteroscopy to see if there are any conditions affecting the womb lining which may be contributing to pregnancy failure.
Read the detailed description
The diagnosis of retained products of conception (RPOC) following miscarriage causes physiological and emotional stress to women and their partners. Additional hospital visits, inpatient admissions and non-evidence-based treatments impose an additional burden on women and healthcare services. Ineffective medical and surgical treatments can prolong symptoms such as bleeding, pain and psychological distress which impacts adversely on quality of life. In addition, future fertility can be delayed or worse, permanently impaired, because of damage and scarring of the womb lining arising from chronic infection or mechanical trauma after conventional 'blind' mechanical evacuation of the uterine cavity.
Recent technological advances in hysteroscopy allow RPOC to be directly visualised and simultaneously removed with greater precision and less trauma to the endometrium with promising results. These 'hysteroscopic tissue removal systems' represent the latest advance in uterine surgery. This technology allows complete excision and removal of intrauterine pathology under direct vision, including removal of RPOC in the inpatient and more recently, the outpatient setting with complete resection and resolution of symptoms without apparent complications. Current evidence suggests that hysteroscopic resection of RPOC is associated with the formation of less intrauterine adhesions, lower rates of incomplete evacuation, and shorter time to subsequent conception, but is based on limited numbers of studies, too small sample sizes to statistically detect differences between treatments, poor reporting of confounders and the absence of randomised studies.
To date, there are no randomised controlled trials investigating the use of outpatient hysteroscopy in the management of RPOC against standard treatment. The investigators therefore aim to perform a pilot randomised control trial to assess the feasibility of undertaking a future substantive full-scale trial to compare routine transvaginal ultrasound scanning and outpatient hysteroscopy for the treatment of RPOC against current standard practice to see if it is more effective in improving fertility and minimising symptomatic morbidity. Furthermore, health service resource use will be evaluated against clinical outcomes to determine the cost-effectiveness of this new pathway.
All women who choose non-surgical management of a first trimester (≤14 weeks gestation) miscarriage will be eligible for recruitment into the study, where informed consent will be taken and baseline assessments will be conducted.
All patients who then have RPOC diagnosed on transvaginal ultrasound scan (TVS) at 8 weeks after the diagnosis of their miscarriage will then be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy ('OPH') or 'standard treatment'. At 'OPH', if RPOC are present, then these will be removed on an intention-to-treat basis. If randomised to the 'standard treatment' arm, management will be based according to current practice (expectant, medical, antibiotic, surgical treatment). Immediately after OPH, all women will be asked to complete a questionnaire exploring the acceptability of the procedure and clinicians will be asked to complete a questionnaire exploring the efficacy of OPH in diagnosing and removing RPOC.
For those who had RPOC, regardless of which treatment they were randomised to, face-to-face consultations will be performed at 14 weeks post-randomisation. These will explore clinical outcomes (symptoms and generic quality of life) and use of additional healthcare resources (e.g. additional investigations / treatments / hospitalisations). All patients, no matter whether they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks post-randomisation to determine clinical pregnancy rates and pregnancy outcomes. All patients who have had a miscarriage or have not fallen pregnant since entering the trial will be offered the chance to undergo a hysteroscopy to see if there is any scar tissue, chronic RPOC or other conditions affecting the womb lining which may be contributing to pregnancy failure; this data will be collected. At this point, patients will discharged from the trial.
The sample size of a future substantive study will partly be determined by the results of this study. This study will aim to recruit 200 women to give a better idea of the number of women with RPOC and the numbers willing to be recruited. After recruitment, the investigators will aim to scan 200 women over a six-month period. Predicated upon a sonographic RPOC rate of 20%, 40 women are expected to have RPOC; 20 women would be randomised to 'OPH' and 20 women to 'nOPH'.
- Conditions
- Retained Products After Miscarriage
- Being tested
- Outpatient hysteroscopy, Expectant management, Medical management, Antibiotic, Surgical management
- Keywords
- ultrasound, hysteroscopy, miscarriage, retained products of conception
- Medical subject headings
- Abortion, Incomplete, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient hysteroscopyProcedure or surgery
Direct visualisation and careful extraction of retained pregnancy tissue using a specific hysteroscopic technology known as a hysteroscopic tissue retrieval system.
Expectant managementBehavioural
Leaving the retained pregnancy tissue alone to pass by itself
Medical managementDrug
Also called misoprostol, mifepristone
Giving medications to contract the womb to pass the retained pregnancy tissue
AntibioticDrug
Also called Augmentin, Co-amoxiclav, Metronidazole, Clindamycin
Giving antibiotics to reduce any inflammation/infection caused by the retained pregnancy tissue allowing it to pass by itself
Surgical managementProcedure or surgery
Also called manual vacuum aspiration, suction evacuation of the uterus, dilatation and currettage
Passing a small cannula/catheter/currette into the womb and mechanically scraping the womb lining to remove the retained pregnancy tissue
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Hysteroscopy | Experimental | Outpatient hysteroscopic morcellation of retained products of conception Receives: Procedure: Outpatient hysteroscopy |
| Standard Treatment | Active comparator | Standard treatment of retained products of conception in the form of expectant management, medical management, antibiotic therapy and/or surgical management (manual vacuum aspiration/suction curettage/dilatation and curettage) Receives: Behavioral: Expectant management; Drug: Medical management; Drug: Antibiotic; Procedure: Surgical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible patients
The number of patients approached that fulfill the eligibility criteria for entry into the trial
Measured: During recruitment - 6 months
Proportion of patients enrolled into the trial
The proportion of eligible women that agree to participate in the trial
Measured: During recruitment - 6 months
Proportion of patients attending scan
The proportion of women that attended the hospital for their 8-week post-miscarriage ultrasound scan
Measured: At ultrasound scan 8 weeks post-miscarriage diagnosis
Proportion of patients attending outpatient hysteroscopy (if randomised to this treatment)
Of the women randomised to hysteroscopic treatment of RPOC, the proportion that attended their appointment
Measured: During outpatient hysteroscopy (if randomised to this treatment)
Proportion of patients attending 14-week follow-up
The proportion of women that attended follow-up at 14 weeks
Measured: 14-week follow up
Proportion of patients attending 26-week follow-up
The proportion of women that attended follow-up at 26 weeks
Measured: 26-week follow up
Proportion of patients attending 52-week follow-up
The proportion of women that attended follow-up at 52 weeks
Measured: 52-week follow up
Acceptability of trial to eligible women
To determine why patients decline participation into the trial or withdraw after consent
Measured: Up to 8 months
Acceptability of ultrasound scan to patients
Acceptability of ultrasound scan to patients as recorded on a questionnaire given to the woman after their ultrasound scan on a 5-point Likert scale
Measured: At ultrasound scan 8 weeks post-miscarriage diagnosis
Acceptability of outpatient hysteroscopy to patients
Acceptability of outpatient hysteroscopy to patients, if randomised to this treatment, as recorded on a questionnaire given to the woman after their hysteroscopy on a 5-point Likert scale
Measured: During outpatient hysteroscopy (if randomised to this treatment)
Robustness of data collection tools
Assessing the completion of the patient and clinician questionnaires during the course of the study to determine how robust/appropriate the data collection tools are (we would expect at least 90% of the forms to be filled out)
Measured: From recruitment of first patient to end of trial (up to 20 months)
Secondary outcomes (14)
Clinical pregnancy rates
Clinical pregnancy rates
Measured: Assessed at 26 and 52 weeks post-randomisation/ultrasound scan
Time to next pregnancy
Time to next pregnancy
Measured: Assessed at 26 and 52 weeks post-randomisation/ultrasound scan
Symptoms
Number of patients with menstrual bleeding, abdominal pain and vaginal discharge symptoms
Measured: 14 weeks post-randomisation/ultrasound scan
Impact on quality of life
Adapted EuroQol- 5 Dimension (EQ-5D-5L)
Measured: 14 weeks post-randomisation/ultrasound scan
Impact on work
Time absent from work
Measured: 14 weeks post-randomisation/ultrasound scan
Healthcare resource use
Number of consultations, scans, inpatient hospital admissions, overnight stays, treatments administered
Measured: 14 weeks post-randomisation/ultrasound scan
Patient satisfaction
Patient satisfaction of trial process (i.e. ultrasound scan +/- treatment for retained products of conception) on a 10cm visual analogue scale
Measured: 14 weeks post-randomisation/ultrasound scan
Procedural findings at ultrasound
Ultrasound findings of patients categorised into whether RPOC are present or not. If RPOC are present, dimensions of RPOC (in millimeters) and presence of vascularity (yes/no) are to be recorded.
Measured: During ultrasound scan 8 weeks post-miscarriage diagnosis
Ease of diagnosis of retained products of conception (RPOC)
Ease of diagnosis of retained products of conception on ultrasound scan by scan operator on a 10cm visual analogue score
Measured: During ultrasound scan 8 weeks post-miscarriage diagnosis
Procedural findings at outpatient hysteroscopy (in women randomised to this treatment)
Hysteroscopic findings/procedural success in women randomised to outpatient hysteroscopy
Measured: During outpatient hysteroscopy (in women randomised to this treatment)
Ease of removal of RPOC during outpatient hysteroscopy (in women randomised to this treatment)
Ease of hysteroscopic morcellation of RPOC and procedural success from clinician perspective, recorded on a 10cm visual analogue scale
Measured: During outpatient hysteroscopy (in women randomised to this treatment)
Pain experienced by patients undergoing outpatient hysteroscopy (in women randomised to this treatment)
Pain experienced by patients undergoing outpatient hysteroscopy on a 10cm visual analogue scale
Measured: During outpatient hysteroscopy (in women randomised to this treatment)
Proportion of women with adverse pregnancy outcomes at 52 weeks
Proportion of women with no pregnancy or failed pregnancy (ectopic pregnancy, miscarriage) at 52-week follow up
Measured: 52 weeks post-randomisation/ultrasound scan
Hysteroscopic findings in women with adverse pregnancy outcomes at 52 weeks
Hysteroscopic findings in women with adverse pregnancy outcomes at 52 weeks
Measured: During outpatient hysteroscopy after 52 weeks post-randomisation/ultrasound scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start31 Jan 2021
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Products After MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves two phases: 1) All recruited women will be scanned for RPOC at 8 weeks post-miscarriage diagnosis. 2) Women that have RPOC on this scan will then be randomised in a 1:1 manner to either outpatient hysteroscopy or standard treatment.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Tommy's
- Responsible party
- Sponsor
- Investigators
- T Justin Clark, FRCOG, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751500
- Sponsor's protocol ID
- 276909
- Other IDs
- 20/WM/0287
- Acronym
- HYMMN
- Status last verified
- Aug 2023
- First submitted
- 29 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any physical paperwork containing identifiable data will be kept in an access-controlled, secured room inside the Birmingham Women's and Children's NHS Foundation Trust in a secure locked office. Anonymised data will be uploaded from the site office to the electronic Remote Data Capture system (eRDC) system, hosted on the University of Birmingham server. The security of the System is governed by the policies of the University of Birmingham. The University's Data Protection Policy and the Conditions of Use of Computing and Network Facilities set out the security arrangements under which sensitive data should be processed and stored. The Study Centre has arrangements in place for the secure storage and processing of the study data which comply with the University of Birmingham policies.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial
- ClinicalTrials.gov ID
- NCT04751500
- Acronym / sponsor ID
- HYMMN / 276909
- Conditions
- Retained Products After Miscarriage
- Keywords
- ultrasound, hysteroscopy, miscarriage, retained products of conception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Tommy's
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy tissue can be found remaining in the womb in up to 20% of women following a miscarriage. These "retained products of conception" (RPOC), which are diagnosed by transvaginal ultrasound, can cause prolonged bleeding, pain, infection, impaired fertility and therefore further psychological distress. Ineffective medical and surgical interventions place considerable burden on affected women and utilise scarce health care resources. Additionally, surgery is performed 'blindly' using a suction tube or metal curette where risks include perforation of the womb and scarring of the womb lining, both of which lead to delayed fertility and in the worst circumstances, infertility.
There is no current guidance on how to best investigate and manage RPOC. New surgical equipment allows RPOC removal under vision, using a specially designed telescope placed inside the womb (hysteroscopy). This precise technique may more successfully and less traumatically remove RPOC, minimising ongoing bleeding, the risk of womb perforation and scar tissue formation, thereby reducing the risk of infertility.
The investigators propose a pilot randomised controlled trial using routine transvaginal ultrasound to diagnose RPOC in women who choose non-surgical management of a first-trimester (≤14 weeks) miscarriage. This scan will be done 8 weeks post-miscarriage diagnosis. Women who have RPOC on this scan will be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy ('OPH') or 'standard treatment' (expectant, medical, surgical and/or antibiotic treatment).
Women who had RPOC will be followed-up at 14 weeks after randomisation to explore clinical outcomes (symptoms, quality of life) and use of additional healthcare resources (e.g. additional investigations / treatments / hospitalisations). All patients, no matter whether they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks after randomisation/ultrasound scan to determine clinical pregnancy rates and pregnancy outcomes. All patients who have had a miscarriage or have not fallen pregnant since entering the trial will be offered a hysteroscopy to see if there are any conditions affecting the womb lining which may be contributing to pregnancy failure.
Detailed description
The diagnosis of retained products of conception (RPOC) following miscarriage causes physiological and emotional stress to women and their partners. Additional hospital visits, inpatient admissions and non-evidence-based treatments impose an additional burden on women and healthcare services. Ineffective medical and surgical treatments can prolong symptoms such as bleeding, pain and psychological distress which impacts adversely on quality of life. In addition, future fertility can be delayed or worse, permanently impaired, because of damage and scarring of the womb lining arising from chronic infection or mechanical trauma after conventional 'blind' mechanical evacuation of the uterine cavity.
Recent technological advances in hysteroscopy allow RPOC to be directly visualised and simultaneously removed with greater precision and less trauma to the endometrium with promising results. These 'hysteroscopic tissue removal systems' represent the latest advance in uterine surgery. This technology allows complete excision and removal of intrauterine pathology under direct vision, including removal of RPOC in the inpatient and more recently, the outpatient setting with complete resection and resolution of symptoms without apparent complications. Current evidence suggests that hysteroscopic resection of RPOC is associated with the formation of less intrauterine adhesions, lower rates of incomplete evacuation, and shorter time to subsequent conception, but is based on limited numbers of studies, too small sample sizes to statistically detect differences between treatments, poor reporting of confounders and the absence of randomised studies.
To date, there are no randomised controlled trials investigating the use of outpatient hysteroscopy in the management of RPOC against standard treatment. The investigators therefore aim to perform a pilot randomised control trial to assess the feasibility of undertaking a future substantive full-scale trial to compare routine transvaginal ultrasound scanning and outpatient hysteroscopy for the treatment of RPOC against current standard practice to see if it is more effective in improving fertility and minimising symptomatic morbidity. Furthermore, health service resource use will be evaluated against clinical outcomes to determine the cost-effectiveness of this new pathway.
All women who choose non-surgical management of a first trimester (≤14 weeks gestation) miscarriage will be eligible for recruitment into the study, where informed consent will be taken and baseline assessments will be conducted.
All patients who then have RPOC diagnosed on transvaginal ultrasound scan (TVS) at 8 weeks after the diagnosis of their miscarriage will then be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy ('OPH') or 'standard treatment'. At 'OPH', if RPOC are present, then these will be removed on an intention-to-treat basis. If randomised to the 'standard treatment' arm, management will be based according to current practice (expectant, medical, antibiotic, surgical treatment). Immediately after OPH, all women will be asked to complete a questionnaire exploring the acceptability of the procedure and clinicians will be asked to complete a questionnaire exploring the efficacy of OPH in diagnosing and removing RPOC.
For those who had RPOC, regardless of which treatment they were randomised to, face-to-face consultations will be performed at 14 weeks post-randomisation. These will explore clinical outcomes (symptoms and generic quality of life) and use of additional healthcare resources (e.g. additional investigations / treatments / hospitalisations). All patients, no matter whether they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks post-randomisation to determine clinical pregnancy rates and pregnancy outcomes. All patients who have had a miscarriage or have not fallen pregnant since entering the trial will be offered the chance to undergo a hysteroscopy to see if there is any scar tissue, chronic RPOC or other conditions affecting the womb lining which may be contributing to pregnancy failure; this data will be collected. At this point, patients will discharged from the trial.
The sample size of a future substantive study will partly be determined by the results of this study. This study will aim to recruit 200 women to give a better idea of the number of women with RPOC and the numbers willing to be recruited. After recruitment, the investigators will aim to scan 200 women over a six-month period. Predicated upon a sonographic RPOC rate of 20%, 40 women are expected to have RPOC; 20 women would be randomised to 'OPH' and 20 women to 'nOPH'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves two phases: 1) All recruited women will be scanned for RPOC at 8 weeks post-miscarriage diagnosis. 2) Women that have RPOC on this scan will then be randomised in a 1:1 manner to either outpatient hysteroscopy or standard treatment.
| Arm | Type | Receives |
|---|---|---|
| Outpatient Hysteroscopy | Experimental | Procedure: Outpatient hysteroscopyOutpatient hysteroscopic morcellation of retained products of conception |
| Standard Treatment | Active comparator | Behavioral: Expectant management, Drug: Medical management, Drug: Antibiotic, Procedure: Surgical managementStandard treatment of retained products of conception in the form of expectant management, medical management, antibiotic therapy and/or surgical management (manual vacuum aspiration/suction curettage/dilatation and curettage) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women above 18 years
- Women choosing either expectant or medical management of a first-trimester miscarriage ≤14 weeks gestation
- Women wanting to conceive as soon as possible after their miscarriage
- Consent to trial processes: (1) undergo follow-up with transvaginal ultrasound for the investigation of RPOC; (2) be randomised to outpatient hysteroscopy for confirmation and treatment or standard management; (3) accept trial follow up procedures - questionnaires, telephone interviews
Key exclusion criteria (4 listed)
- Women below 18 years
- Women with findings suspicious of gestational trophoblastic disease
- Women with fever (≥38°C) or sepsis secondary to genital tract infection/endometritis
- Women who are unable to understand spoken and written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient hysteroscopyDirect visualisation and careful extraction of retained pregnancy tissue using a specific hysteroscopic technology known as a hysteroscopic tissue retrieval system. | Procedure or surgery | Outpatient Hysteroscopy |
| Expectant managementLeaving the retained pregnancy tissue alone to pass by itself | Behavioural | Standard Treatment |
| Medical managementAlso: misoprostol, mifepristoneGiving medications to contract the womb to pass the retained pregnancy tissue | Drug | Standard Treatment |
| AntibioticAlso: Augmentin, Co-amoxiclav, Metronidazole, ClindamycinGiving antibiotics to reduce any inflammation/infection caused by the retained pregnancy tissue allowing it to pass by itself | Drug | Standard Treatment |
| Surgical managementAlso: manual vacuum aspiration, suction evacuation of the uterus, dilatation and currettagePassing a small cannula/catheter/currette into the womb and mechanically scraping the womb lining to remove the retained pregnancy tissue | Procedure or surgery | Standard Treatment |
Primary outcome
Number of eligible patients
Time frame: During recruitment - 6 months
The number of patients approached that fulfill the eligibility criteria for entry into the trial
Proportion of patients enrolled into the trial
Time frame: During recruitment - 6 months
The proportion of eligible women that agree to participate in the trial
Proportion of patients attending scan
Time frame: At ultrasound scan 8 weeks post-miscarriage diagnosis
The proportion of women that attended the hospital for their 8-week post-miscarriage ultrasound scan
Proportion of patients attending outpatient hysteroscopy (if randomised to this treatment)
Time frame: During outpatient hysteroscopy (if randomised to this treatment)
Of the women randomised to hysteroscopic treatment of RPOC, the proportion that attended their appointment
Proportion of patients attending 14-week follow-up
Time frame: 14-week follow up
The proportion of women that attended follow-up at 14 weeks
Proportion of patients attending 26-week follow-up
Time frame: 26-week follow up
The proportion of women that attended follow-up at 26 weeks
Proportion of patients attending 52-week follow-up
Time frame: 52-week follow up
The proportion of women that attended follow-up at 52 weeks
Acceptability of trial to eligible women
Time frame: Up to 8 months
To determine why patients decline participation into the trial or withdraw after consent
Acceptability of ultrasound scan to patients
Time frame: At ultrasound scan 8 weeks post-miscarriage diagnosis
Acceptability of ultrasound scan to patients as recorded on a questionnaire given to the woman after their ultrasound scan on a 5-point Likert scale
Acceptability of outpatient hysteroscopy to patients
Time frame: During outpatient hysteroscopy (if randomised to this treatment)
Acceptability of outpatient hysteroscopy to patients, if randomised to this treatment, as recorded on a questionnaire given to the woman after their hysteroscopy on a 5-point Likert scale
Robustness of data collection tools
Time frame: From recruitment of first patient to end of trial (up to 20 months)
Assessing the completion of the patient and clinician questionnaires during the course of the study to determine how robust/appropriate the data collection tools are (we would expect at least 90% of the forms to be filled out)
14 secondary outcomes
Clinical pregnancy rates
Time frame: Assessed at 26 and 52 weeks post-randomisation/ultrasound scan
Time to next pregnancy
Time frame: Assessed at 26 and 52 weeks post-randomisation/ultrasound scan
Symptoms
Time frame: 14 weeks post-randomisation/ultrasound scan
Impact on quality of life
Time frame: 14 weeks post-randomisation/ultrasound scan
Impact on work
Time frame: 14 weeks post-randomisation/ultrasound scan
Healthcare resource use
Time frame: 14 weeks post-randomisation/ultrasound scan
Patient satisfaction
Time frame: 14 weeks post-randomisation/ultrasound scan
Procedural findings at ultrasound
Time frame: During ultrasound scan 8 weeks post-miscarriage diagnosis
Ease of diagnosis of retained products of conception (RPOC)
Time frame: During ultrasound scan 8 weeks post-miscarriage diagnosis
Procedural findings at outpatient hysteroscopy (in women randomised to this treatment)
Time frame: During outpatient hysteroscopy (in women randomised to this treatment)
Ease of removal of RPOC during outpatient hysteroscopy (in women randomised to this treatment)
Time frame: During outpatient hysteroscopy (in women randomised to this treatment)
Pain experienced by patients undergoing outpatient hysteroscopy (in women randomised to this treatment)
Time frame: During outpatient hysteroscopy (in women randomised to this treatment)
Proportion of women with adverse pregnancy outcomes at 52 weeks
Time frame: 52 weeks post-randomisation/ultrasound scan
Hysteroscopic findings in women with adverse pregnancy outcomes at 52 weeks
Time frame: During outpatient hysteroscopy after 52 weeks post-randomisation/ultrasound scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. Any physical paperwork containing identifiable data will be kept in an access-controlled, secured room inside the Birmingham Women's and Children's NHS Foundation Trust in a secure locked office. Anonymised data will be uploaded from the site office to the electronic Remote Data Capture system (eRDC) system, hosted on the University of Birmingham server. The security of the System is governed by the policies of the University of Birmingham. The University's Data Protection Policy and the Conditions of Use of Computing and Network Facilities set out the security arrangements under which sensitive data should be processed and stored. The Study Centre has arrangements in place for the secure storage and processing of the study data which comply with the University of Birmingham policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T Justin Clark, FRCOG principal investigator
Birmingham Women's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient hysteroscopy, Expectant management and Medical management in people with Retained Products After Miscarriage, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible patients (time frame: During recruitment - 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.